Catalog Number 1012274-15T |
Device Problems
Material Rupture (1546); Physical Resistance (2578)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The tenku is not commercially available for sale in the u.S; however, it is similar to a device currently marketed for sale in the u.S.
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Event Description
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It was reported that the procedure was to treat a de novo lesion in the moderately tortuous, concentric, mildly calcified, 90% stenosed, mid, left anterior descending (lad) coronary artery with a 3.00 x 15 mm tenku rx balloon dilatation catheter (bdc).The bdc was advanced toward the with slight resistance felt, crossed and upon the first inflation to 6 atmospheres the balloon ruptured.The bdc was removed from the anatomy with no resistance felt.A new non-abbott 3.00 x 15 mm bdc was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Search Alerts/Recalls
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